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Overview

The Yellow Card Scheme is vital in helping the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.

Reports can be made for:

suspected adverse drug reactions (ADRs) to all medicines including:

vaccines

blood factors and immunoglobulins

herbal medicines

homeopathic remedies

all medical devices available on the UK market

defective medicines (those that are not of an acceptable quality)

fake or counterfeit medicines or medical devices

It is important that problems with medicines and medical devices are reported, as the reports help identify new problems with these products.

MHRA will review the product and if necessary and take action to minimise risk and maximise benefit to the patients.

MHRA is also able to investigate counterfeit medicines or devices and if necessary take action.

What to report

Medicines

For established medicines and vaccines you should report all serious suspected ADRs, even if the effect is well recognised.

We are particularly interested in receiving Yellow Card reports of suspected ADRs:

You do not have to prove causality to report a suspected ADR, only a suspicion is needed.

Black triangle scheme

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristic, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe.
You should report all suspected ADRs for these products.

Medical devices

Any adverse incident involving a medical device should be reported.

If a device has been involved in an incident it should be quarantined if possible. Do not throw them away, repair them or return them to the manufacturer until MHRA has carried out its own investigation. Do not send medical devices to MHRA unless specifically requested.

If you want to report an incident with a medical device in Scotland you should report it to Health Facilities Scotland unless you are a private facility providing care to private clients, in which case you should report to MHRA and the Care Inspectorate.

E-learning modules for pharmacists

The Centre for Postgraduate Pharmacy Education (CPPE) has developed a series of 3 e-learning programmes with the Wales Centre for Pharmacy Professional Education and MHRA. The programme has been endorsed by the Drug Safety Research Unit.

The e-learning modules should help pharmacists understand how to identify, report and prevent ADRS.